Heart valve prosthesis and methods of manufacture and use

Abstract

A heart valve prosthesis is provided having a self-expanding multi-level frame that supports a valve body comprising a skirt and plurality of coapting leaflets. The frame transitions between a contracted delivery configuration that enables percutaneous transluminal delivery, and an expanded deployed configuration having an asymmetric hourglass shape. The valve body skirt and leaflets are constructed so that the center of coaptation may be selected to reduce horizontal forces applied to the commissures of the valve, and to efficiently distribute and transmit forces along the leaflets and to the frame. Alternatively, the valve body may be used as a surgically implantable replacement valve prosthesis.

What is claimed is: 
     
       1. A valve prosthesis comprising:
 a valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures; and 
 a self-expanding frame comprising an inflow section having a first row of cells in a circumferentially repeating pattern, and an outflow section having a second row of cells in a circumferentially repeating pattern; 
 wherein a first area of individual cells in the first row of cells is less than a second area of individual cells in the second row of cells; 
 wherein the frame has a contracted delivery configuration and an expanded deployed configuration, wherein, when the frame is in the expanded deployed configuration, the outflow section has an outflow section diameter that is larger than an inflow section diameter; 
 wherein the frame supports the valve body, wherein the skirt has a bottom edge sewn to an inflow edge of the frame and the commissures are sewn to the frame between the first and second rows of cells such that a center of coaptation of free edges of the leaflets is closer to the inflow edge of the frame than the commissures are to the inflow edge of the frame. 
 
     
     
       2. The valve prosthesis of  claim 1 , wherein the frame comprises a middle region between the inflow section and the outflow section, wherein in the expanded deployed configuration, a middle region diameter of the middle region is smaller than the inflow section diameter. 
     
     
       3. The valve prosthesis of  claim 1 , wherein the outflow section includes a plurality of eyelets. 
     
     
       4. The valve prosthesis of  claim 1 , wherein the skirt further comprises a plurality of end tabs affixed to the first row of cells. 
     
     
       5. The valve prosthesis of  claim 1 , wherein the frame has proximal and distal ends and a plurality of cell patterns that vary in size between the proximal and distal ends. 
     
     
       6. The valve prosthesis of  claim 1 , wherein the leaflets comprise porcine, bovine, equine or other mammalian pericardial tissue, synthetic material or polymeric material. 
     
     
       7. The valve prosthesis of  claim 1 , wherein the valve prosthesis is configured to hold a patient's native valve permanently open in the expanded deployed configuration. 
     
     
       8. The valve prosthesis of  claim 1 , wherein the outflow section diameter is between 30 mm and 55 mm and the inflow section diameter is between 19 mm and 34 mm. 
     
     
       9. The valve prosthesis of  claim 1 , wherein the frame includes four rows of cells. 
     
     
       10. The valve prosthesis of  claim 1 , wherein a base of each leaflet of the plurality of leaflets is affixed to the skirt along a joint that follows a contour of the frame such that most of the joint is directly supported by the frame. 
     
     
       11. The valve prosthesis of  claim 1 , wherein the leaflets comprise animal pericardial tissue. 
     
     
       12. The valve prosthesis of  claim 11 , wherein the skirt comprises animal pericardial tissue. 
     
     
       13. The valve prosthesis of  claim 12 , wherein the leaflets and the skirt have a thickness between 0.008 inch and 0.016 inch. 
     
     
       14. The valve prosthesis of  claim 12 , wherein the leaflets and the skirt have a thickness between 0.012 inch and 0.014 inch. 
     
     
       15. The valve prosthesis of  claim 11 , wherein the leaflets have a thickness between 0.008 inch and 0.016 inch. 
     
     
       16. The valve prosthesis of  claim 11 , wherein the leaflets have a thickness between 0.012 inch and 0.014 inch. 
     
     
       17. The valve prosthesis of  claim 11 , wherein the skirt comprises a synthetic or polymer material. 
     
     
       18. The valve prosthesis of  claim 17 , wherein the skirt has a thickness between 0.004 inch and 0.012 inch. 
     
     
       19. The valve prosthesis of  claim 17 , wherein the skirt has a thickness between 0.006 inch and 0.008 inch. 
     
     
       20. A valve prosthesis comprising:
 a valve body comprising a plurality of leaflets affixed to a skirt, adjoining leaflets affixed together to form commissures; and 
 a self-expanding frame comprising an inflow section, an outflow section including two eyelets, and a middle region disposed between the inflow section and the outflow section, the middle region including a plurality of cells; 
 wherein the frame has a contracted delivery configuration and an expanded deployed configuration, wherein, when the frame is in the expanded deployed configuration, an outflow section diameter is larger than an inflow section diameter and the inflow section diameter is larger than a middle region diameter; 
 wherein the frame supports the valve body, wherein the commissures are sewn to the frame in the middle region, and wherein each commissure spans only a single cell of the plurality of cells of the middle region. 
 
     
     
       21. The valve prosthesis of  claim 20 , wherein the inflow section diameter is between 19 mm and 34 mm and the outflow section diameter is between 30 mm and 55 mm.